SARECYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for sarecycline hydrochloride and what is the scope of patent protection?

Sarecycline hydrochloride is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sarecycline hydrochloride has seventy-one patent family members in twenty countries.

One supplier is listed for this compound.

Summary for SARECYCLINE HYDROCHLORIDE

International Patents:	71
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	6
Patent Applications:	12
What excipients (inactive ingredients) are in SARECYCLINE HYDROCHLORIDE?	SARECYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	SARECYCLINE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SARECYCLINE HYDROCHLORIDE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SARECYCLINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beijing Tiantan Hospital	Phase 2
NeuroDawn Pharmaceutical Co., Ltd.	Phase 2
Derm Research, PLLC	Phase 4

See all SARECYCLINE HYDROCHLORIDE clinical trials

Pharmacology for SARECYCLINE HYDROCHLORIDE

Drug Class	Tetracycline-class Drug
Mechanism of Action	P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SARECYCLINE HYDROCHLORIDE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SARECYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-001	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-002	Oct 1, 2018		RX	Yes	No			Y	Y
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521-003	Oct 1, 2018		RX	Yes	Yes			Y	Y

International Patents for SARECYCLINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Turkey	201911086
Denmark	2707003
Slovenia	2120963
Canada	2835876	SELS CRISTALLINS D'AMIDE DE L'ACIDE (4S,4AS,5AR,12AS)-4-DIMETHYLAMINO- 3,10,12,12A-TETRAHYDROXY-7-[(METHOXY(METHYL)AMINO)-METHYL]- 1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTACENE-2-CARBOXYLIQUE ET PROCEDES D'UTILISATION ASSOCIES (CRYSTALLINE SALTS OF (4S,4AS,5AR,12AS)-4-DIMETHYLAMINO-3,10,12,12A-TETRAHYDROXY-7-[(METHOXY(METHYL)AMINO)-METHYL]-1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTHACENE-2-CARBOXYLIC ACID AMIDE AND METHODS OF USING THE SAME)
European Patent Office	2450347	Dérivés de tétracycline pour le traitement d'infections bactériennes, virales et parasites (Tetracycline derivatives for the treatment of bacterial, viral and parasitic infections)
European Patent Office	3812372	DÉRIVÉS DE SANCLYCINE SUBSTITUÉS PAR 7-HÉTÉROCYCLYL POUR LE TRAITEMENT D'INFECTIONS BACTÉRIENNES, VIRALES, ET PARASITAIRES (P.E. MALARIA) OU MALADIES INFLAMMATOIRES (7-HETEROCYCLYL SUBSTITUTED SANCYCLINE DERIVATIVES FOR TREATING BACTERIAL, VIRAL AND PARASITIC INFECTIONS (E.G. MALARIA) OR INFLAMMATORY DISEASES)
Japan	6061897

SARECYCLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sarecycline Hydrochloride (Seysara)

Introduction

Sarecycline hydrochloride, marketed under the brand name Seysara, is a novel, narrow-spectrum tetracycline derivative approved by the U.S. Food and Drug Administration (FDA) in October 2018 for the treatment of inflammatory non-nodular moderate to severe acne vulgaris. Here, we delve into the market dynamics and financial trajectory of this drug.

Development and Licensing

Sarecycline was initially developed by Paratek Pharmaceuticals, Inc., and later licensed to Warner Chilcott, which was subsequently acquired by Allergan PLC. Allergan assigned the U.S. development and commercialization rights to Almirall, S.A., while Paratek retained the rights for the rest of the world[2][5].

FDA Approval and Market Entry

The FDA approval of Seysara marked a significant milestone, as it introduced a new first-in-class narrow-spectrum tetracycline-derived antibiotic to the market. This approval was a result of extensive clinical trials, including phase II and phase III studies, which demonstrated the drug's efficacy and safety in treating moderate to severe acne vulgaris in patients 9 years of age and older[1][5].

Market Positioning

Seysara is positioned as a once-daily oral therapy with anti-inflammatory properties, targeting the treatment of acne in the community setting. Its narrow spectrum of antibacterial activity reduces the risk of off-target effects on the intestinal flora, making it a preferable option over broad-spectrum tetracyclines. This unique profile helps in minimizing adverse effects such as diarrhea and fungal overgrowth, which are common with other tetracycline therapies[1][5].

Competitive Landscape

The acne treatment market is competitive, with several established tetracycline therapies like doxycycline and minocycline. However, Seysara's narrow spectrum and lower propensity for resistance development set it apart. It is active against tetracycline-resistant Staphylococcus aureus and erythromycin- and clindamycin-resistant Cutibacterium acnes strains, making it a valuable addition to the treatment options for acne vulgaris[5].

Financial Aspects

Milestone Payments and Royalties

Upon FDA approval, Paratek Pharmaceuticals earned a $12 million milestone payment. Additionally, the company is entitled to receive tiered royalties ranging from high-single to low double digits on net sales of Seysara in the U.S.[2].

Revenue Projections

The financial trajectory of Seysara is influenced by its market performance and sales forecasts. GlobalData's NPV models provide detailed revenue forecasts, which are crucial for strategic decision-making. These models consider factors such as patent law, regulatory approval processes, cash flows, and pricing estimates to predict the drug's financial performance over a 17-year period[3].

Market Penetration

Almirall, S.A., which acquired Allergan's U.S. Medical Dermatology portfolio, is responsible for marketing Seysara in the U.S. This acquisition has helped Almirall reinforce its presence in the dermatology market. The drug's market penetration is expected to grow as it gains acceptance among dermatologists and patients due to its unique benefits and efficacy profile[1][2].

Clinical and Regulatory Success

Seysara has undergone rigorous clinical testing, including 18 completed clinical studies, which include phase I, phase II, and three phase III studies. These studies have established it as a well-tolerated once-daily oral drug. The drug's approval and successful clinical trials have been pivotal in its market acceptance and financial performance[4][5].

Future Development and Indications

In addition to its approved indication for acne vulgaris, sarecycline was also under development for the treatment of rosacea. Although this development is not as advanced, it presents potential future revenue streams and market expansion opportunities[3].

Key Takeaways

• Unique Mechanism: Seysara's narrow spectrum of antibacterial activity and lower propensity for resistance development make it a preferred treatment option for moderate to severe acne vulgaris.
• Market Positioning: It is marketed as a once-daily oral therapy with anti-inflammatory properties, targeting community-based acne treatment.
• Financial Performance: The drug generates revenue through milestone payments and tiered royalties, with significant potential for growth based on market forecasts.
• Regulatory Success: Extensive clinical trials and FDA approval have solidified its position in the market.
• Future Potential: Potential expansion into treating rosacea and other indications could further enhance its market presence and financial trajectory.

FAQs

What is sarecycline hydrochloride used for?

Sarecycline hydrochloride, marketed as Seysara, is used for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older[1][5].

Who developed and licensed sarecycline?

Sarecycline was initially developed by Paratek Pharmaceuticals, Inc., and later licensed to Warner Chilcott, which was subsequently acquired by Allergan PLC. Allergan assigned the U.S. development and commercialization rights to Almirall, S.A.[2][5].

What makes sarecycline unique compared to other tetracyclines?

Sarecycline has a narrow spectrum of antibacterial activity, which reduces off-target effects on the intestinal flora, and it has a lower propensity for resistance development. It is also active against tetracycline-resistant and other antibiotic-resistant strains of bacteria[1][5].

How is sarecycline administered?

Sarecycline is administered orally as a once-daily film-coated tablet, available in strengths of 60 mg, 100 mg, and 150 mg[4].

What are the financial implications of FDA approval for Paratek Pharmaceuticals?

Upon FDA approval, Paratek earned a $12 million milestone payment and is entitled to receive tiered royalties on net sales of Seysara in the U.S.[2].

Sources

1. DrugBank Online: Sarecycline hydrochloride | DrugBank Online
2. Biospace: FDA Approves SEYSARA™ (Sarecycline) for the Treatment of ...
3. GlobalData: Net Present Value Model: Seysara - GlobalData
4. FDA: 209521Orig1s000ChemR.pdf
5. PubMed: Sarecycline hydrochloride for the treatment of acne vulgaris - PubMed